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Behavioural Intervention

Acceptance and Commitment Therapy for Depression in Spinal Cord Injury

N/A

Recruiting

Led By Areum Han, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

community-dwelling adults (aged 18 years or older) living with spinal cord injuries

having at least mild depressive symptoms as measured by the PHQ-9 (scores ≥ 5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of an 8-week videoconferencing therapy program on improving mental health outcomes in individuals living with spinal cord injury (SCI) who are experiencing depressive symptoms. The

Who is the study for?

This trial is for adults over 18 with spinal cord injuries who feel at least mildly depressed, as shown by a PHQ-9 score of 5 or more. Participants need internet access and a device like a computer or smartphone to join the videoconferencing sessions.

What is being tested?

The study tests if Acceptance and Commitment Therapy (ACT) delivered through video calls can help improve mental health in people with spinal cord injuries and depression. It compares an 8-week ACT program with a wait-list group that continues usual care.

What are the potential side effects?

ACT typically doesn't have physical side effects but may bring up uncomfortable emotions as participants work through their thoughts and feelings related to their injury and life changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult living with a spinal cord injury.

Select...

I have mild or more severe depression symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9)

Secondary study objectives

Change from baseline to immediately after the intervention (or 2 weeks) and 2 month follow-up on the Cognitive Fusion Questionnaire -7 (CFQ-7)

Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Action and Acceptance Questionnaire-II (AAQ-II)

Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance and commitment therapy (ACT) groupExperimental Treatment1 Intervention

The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up.

Group II: Wait-list control groupActive Control1 Intervention

The wait-list control group will maintain his or her own care as usual during the study period and receive eight individual ACT sessions after study participation ends.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and commitment therapy (ACT)

2022

N/A

~40

0 / 2Eligibility criteria met